Drugs, pharmaceutical controlled substances

Controlled Substance Act and Controlled Substances Import and Export Act. Removed regulation of drug abuse from FDA (transferred to the Drag Enforcement Agency) and provided for stringent regulation of pharmaceuticals with abuse potential. 

Codeine is a natural alkaloid found in the opium plant. As a pharmaceutical, codeine is used as an analgesic, antitussive, and antidiar-rheal. Codeine is also commonly combined with other cough suppressants as well as with aspirin and ibuprofen. In the United States, codeine is a Schedule III controlled substance, which means that its distribution is more tightly regulated than unscheduled drugs. Codeine has pain-relieving qualities principally because, once in the body, about 10 percent of codeine turns into morphine. This conversion occurs in the liver, where an enzyme changes codeine s... 

By 1972, luding out —taking methaqualone with wine—was popular on college campuses. Excessive use of the drug leads to tolerance, dependence, and withdrawal symptoms similar to those of barbiturates. Overdose by methaqualone is more difficult to treat than barbiturate overdose, and deaths have frequently occurred. In the United States, the marketing of methaqualone pharmaceutical products was discontinued in 1984, and the drug became a Schedule I controlled substance. However, some level of occasional abuse has continued. 

FdPLC has contributed many successes in product development and in quality control for the pharmaceutical industry. The UV detector coupling with HPLC equipment is the most important analytical instrument for preformulation, QC/QA, and in-process control in pharmaceutical analysis. HPLC is a basic and reliable analytical tool for preformulation study because of the high-resolution capacity, accuracy, and reproducibility of the equipment. Its primary function includes search for and detection of impurities in drug substances, as well as stability evaluation of dosage forms in terms of detection and quantitation of degradation products. 

It will check for equivalence, for both the drug substance and pharmaceutical product, between that used in the pivotal clinical studies, the pivotal stability studies and commercial production. This is usually achieved by inspecting product and control data such as clinical trial batch records, in-process and end-product test results and raw material, component and product specifications. During an R D PAI the FDA will also check for general compliance with cGMP, will inspect the facilities and equipment used and check the appropriateness of control systems and procedures. 

In terms of the quahty control of drugs, this trend will close the circle of experience that is already available. In former times, many pharmacologically active substances were extracted from plants, and indeed some of these are stiU used today in estabhshed natural medicines. As with all other pharmaceutical products, a series of analytical techniques was estabhshed in order to describe the reproducible quahty of such preparations. Today, however, new analytical tools for modern biopharmaceuticals may be used to optimize and simplify the proper characterization of existing drags, one example being that of pro-biotic pharmaceuticals [9]. 

The purpose of this regulation is to rule the manufacturing practices of high quality drugs,pharmaceuticals, medical preparations, substances, materials and compositions and the establishment, business practices and control of relevant manufacturing premises. 

Microencapsulated solid preparations are widely used in pharmaceutical, chemical, and other industries to protect various substances from environmental impact, as well as for extending their action [137], In the pharmaceutical field, in particular, these preparations are mainly used to get controlled release drug kinetics, to minimize side effects, to reduce gastric irritations, and to mask the unpleasant taste of the contained drug [137-142]. Indeed, many different active components are microencapsulated analgesics, antibiotics, antihistamine, cardiovascular agents, iron salts, antipsychot-ics [143], vitamins, peptides [144], proteins [145], antiasthma [140,146], broncodilators, diuretics, anticancerogens, tranquilizers, and antihypertensives [137],... 

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